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NCT02022215 Clinical Trial

Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

Onychomycosis Clinical Trial

Official title:
A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of ME1111 in Patients With Mild to Moderate Onychomycosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02022215
Other study ID # ME1111-2
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 19, 2013
Est. completion date March 1, 2016

Study information
Verified date March 2024
Source Meiji Seika Pharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.

Recruitment information / eligibility
Status Completed
Enrollment 304
Est. completion date March 1, 2016
Est. primary completion date October 28, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Mild to moderate distal lateral subungual onychomycosis - A positive potassium hydroxide (KOH) microscopy - A positive fungal culture for a dermatophyte - Good general health Exclusion Criteria: - Uncontrolled diabetes - Onychomycosis of the fingernails - Prior use of antifungal drugs (Failure to complete the specified washout period) - History of HIV, Hepatitis B or Hepatitis C - Diagnosis of psoriasis or history of psoriasis - Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study - Pregnancy/lactation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ME1111 Solution, Low strength
ME1111 Solution, Low strength, applied once daily for 48 weeks
• ME1111 Solution, High strength
ME1111 Solution, High strength, applied once daily for 48 weeks
• Matching Vehicle Solution
Matching Vehicle Solution, applied once daily for 48 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Meiji Seika Pharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete cure rate at Week 52 complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure. Week 52
Secondary Complete or almost complete cure rate at Week 52 complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure. Week 52
Secondary Number of Adverse events Up to Week 48, Week 52, EOS
Secondary Local Tolerability Assessments Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting. Up to Week 48, Week 52, EOS
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